The present invention relates generally to surgical instruments, and more specifically to devices for the suturing of punctures in blood vessels, internal organs and internal tissues accessed via a tissue tract.
Many surgical procedures require the insertion of catheters and/or surgical devices into blood vessels and other internal structures. For example, in the treatment of vascular disease, it is often necessary to insert an instrument such as a catheter into the blood vessel to perform the treatment procedure. Such treatment procedures often involve piercing a wall of the blood vessel, inserting an introducer sheath into the blood vessel via the opening, and maneuvering the procedural catheter through the introducer sheath to a target location within the blood vessel. Such procedures also involve the insertion of a guide wire into the blood vessel tract to help guide tools to perform treatments at the target location. Of course, at the end of such a procedure, the opening in the wall of the blood vessel must be sealed to prevent bleeding while facilitating healing of the wound. This sealing has commonly been accomplished by the application of direct pressure over the puncture site by a physician or other trained medical professional. However, this technique is time consuming and may lead to complications such as thrombosis, which may be dangerous to the patient.
Other sealing techniques include the application of a sealing member or plug of material (most often biogenic sealing material) over the opening in the blood vessel to seal the wound. However, proper placement of sealing members and plugs is difficult to achieve and materials left inside the body may pose serious health risks to the patient if, for example, the material enters the blood stream.
The present invention is directed to a device for sealing a puncture in an anatomical structure, the device comprising a proximal portion having a needle insertion lumen extending therethrough to a needle insertion opening, a distal portion including a needle receiving opening facing the needle insertion opening across a tissue receiving gap and opening into a distal lumen and a connecting portion coupled between the proximal and distal portions and offset from the proximal and distal portions to create the tissue receiving gap whereby, when the connecting portion is received within a puncture in an anatomical structure, a portion of the anatomical structure received within the tissue receiving gap is located between the needle insertion opening and the needle receiving opening.
The distal lumen extends from the needle receiving opening to a guide wire opening located distally in the distal portion of the device. The distal lumen is sized to accommodate a guide wire, such as would be typically used during vascular procedures.
The device can be inserted into the puncture by slipping the proximal end of the guide wire into the guide wire opening of the device, through the distal lumen, and out of the needle receiving opening. The device may then be slid along the guide wire. The guide wire can then be removed so that the device can be placed in the desired position in the puncture and the suturing procedure can begin, upon removal of the guide wire, the distal lumen will have room to receive the suturing needles.
Running the guide wire coaxially through the distal lumen of the device helps to avoid over-dilation of the puncture by eliminating the need for a side-by-side arrangement of the device and guide wire through the puncture. The distal lumen is also useful for reinserting the guide wire through the puncture, if such reinsertion becomes necessary. This arrangement also allows the distal portion of the device to be shorter, since it is not necessary to include separate lumens for capturing the suturing needles and for guiding the device along the guide wire.
In addition, the present invention is directed to a method for sealing a puncture in an anatomical structure including the steps of inserting into the puncture a device having a needle insertion opening and a needle receiving opening separated by a tissue receiving gap and positioning the device so that the needle insertion opening is located on a proximal side of the anatomical structure and the needle receiving opening is located on a distal side of the anatomical structure with a first portion of the anatomical structure received within the tissue receiving gap. At the suturing stage of a medical procedure, a guide wire will often still be running through the puncture into the anatomical structure. Insertion of the device can be accomplished by inserting the proximal end of guide wire into the guide wire opening and sliding the guide wire through the distal lumen until the device is in the desired position. The guide wire is then removed from the distal lumen through the needle receiving opening before the arch section enters the skin line and before inserting suturing needles.
A first needle coupled to a first portion of suture is inserted distally through the needle lumen to exit the device via the needle insertion opening, penetrate the first portion of the anatomical structure and re-enter the device via the distal lumen and the device is rotated so that a second portion of the anatomical structure is located within the tissue receiving gap between the needle insertion opening and needle receiving opening. Then a second needle coupled to a second portion of suture is inserted distally through the needle lumen to exit the device via the needle insertion opening, penetrate the second portion of the anatomical structure and re-enter the device via the distal lumen. The device is withdrawn from the anatomical structure and the first and second portions of suture are tightened to draw the sides of the puncture together.